Non-immersive Virtual Reality for Pediatric Pain Management

Claudia Aristizábal

Status: Completed

Conditions: Procedural Pain

Treatments: Device: Distraction with virtual reality; Other: Treatment as Usual

Study type: Interventional

Funder types: Other

Identifiers

NCT03985930

VRPedPain

Details and patient eligibility

About

This is a multicenter, randomized, clinical trial comparing treatment as usual to distraction with video projection or virtual reality in the management of pediatric (3-6 years) pain associated with venipuncture, intramuscular injection, and vaccination.

Full description

Background: Recent studies have shown that the use of virtual reality (VR) may be useful to provide distraction that attenuates pain in minimally invasive procedures in preschool children.

Aim: To assess the effectiveness of non-immersive virtual reality as a pain-distraction measure in children between the ages of 3 to 5 years undergoing painful injection procedures in an outpatient setting.

Method: This clinical trial will recruit patients under 6 years of age treated at participating medical centers in whom a painful procedure like vaccination, venipuncture or administration of intramuscular medication will be performed. The experimental group will consist of two subgroups which, in addition to treatment as usual, will be distracted using virtual reality content delivered through goggles. The control group will receive treatment as usual. The LLANTO pain scale will be used to measure different characteristics of pain. This scale has been validated in Colombia, and will be filled by two health professionals (one of which will perform the painful procedure.) and the parents.

Expected results: To show that virtual reality or projector distraction are effective distraction tools in pain management for children subjected to painful procedures of venipuncture, intramuscular medication administration, and vaccination.

Enrollment: 122 patients

Sex: All

Ages: 3 to 5 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Patients subjected to procedures of venipuncture, intramuscular injections, or vaccination at participating medical centers.

Exclusion criteria

• Fever (Axillary temperature greater than 38°C).
• Systemic Inflammatory Response Syndrome or Sepsis.
• Pulmonary disease.
• Neurological deficit of any kind.
• Susspected or confirmed metabolic disease.
• Undernutrition or obesity as defined by deviations from the mean of local values.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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122 participants in 2 patient groups

Distraction Group

Experimental group

Description:

Children between the ages of 3 and 5 years will be distracted using virtual reality content delivered through goggles.

Treatment:

Device: Distraction with virtual reality

Treatment as Usual

Active Comparator group

Description:

Children randomized to this group will receive the usual medical care.

Treatment:

Other: Treatment as Usual